Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C751M | OT |
temperature excursion for IPOL as max/low temperature reached: 53 F 45 mins with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that had temperature excursion as max/low temperature reached: 53 F 45 mins with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (lot W1C751M and expiry date: 18-Nov-2025) (strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and that had temperature excursion as max/low temperature reached: 53 F 45 mins with no reported adverse event (poor quality product administered). Reportedly, Reason: Broken refrigerator. Human error was No. Extended stability data did not cover the excursion. Product was administered post excursion. The caller states that this was such a short excursion what if the dose was valid, would it hurt them to get another dose. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.